Clinical Precision

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such drug legal battles need to be avoided at all cost. “Such incidents do create a bit of a concern among clients, especially in cases where there is a lot of media hype and propaganda involved. While the position of the government on patents is well known and it is supportive of IP rights, we will have more such debates and patent challenges in the years to come especially in grey areas under the law,” says Anand Bidarkar, vice-president (business development), SIRO Clinpharm Pvt Ltd. Industry is quick to point out the instance set by China when it went out of its way to protect the IP of Pfizer’s Viagra in order to woo drug companies.

Indian clinical research organisations (CROs) need to move up the value chain and start offering integrated services from trials to clinical supplies and to data management, thereby making trials more efficient. “We are in a dynamic situation and success, if calculated in terms of volumes and value, has no meaning. Ultimate success will be determined by not ‘how many’ and ‘how much’ but by ‘how fast’ and ‘how meaningful,” says Vasi Reddy, chairman, Vimta Laboratories.

There is no doubt that the cost of doing clinical trials in the US and Europe is absolutely prohibitive and pharmaceutical and biotech companies can save millions of dollars by shifting some of those trials to India. Brijesh Regal, CEO, Apothecaries Clinical Research says, the cost per patient for trials in India is approximately 40 to 60% of the cost in western nations.

Based on these advantages, the number of clinical trials in India is expected to grow exponentially over the next five to ten years. “Globally, the market for clinical trials and data management is estimated at around $45 billion and there is potential to outsource 50-60% of it to destinations like India. At present, the Indian market is estimated to be around $1 billion. There is thus immense potential for growth and India could easily conduct 15% of global trials by 2011,” says Shiv Raman Dugal, chairman, Institute of Clinical Research (India).